Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent regulatory strategy required by investors.
In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?
The physician has a unique perspective that non-clinical investors don’t: they know firsthand whether a technology will be adopted. They deeply understand if it truly is better for them and their patients.
Recor Medical Announces Paradise Ultrasound Renal Denervation System Receives Manufacturing and Marketing Approval in Japan for the Treatment of Resistant Hypertension.
Terumo Corporation is acquiring OrganOx Limited to enhance organ preservation technology and address transplant challenges globally. Acquisition marks Terumo entry into transplant sector.
While Zimmer has been able to maintain the largest market share over the past decade, competition in the knee reconstruction space is no longer limited to pricing or incremental design improvements. It is evolving into a battle of technological sophistication and long-term clinical outcomes.
The company initiated trials for AGENT DCB, a drug-coated coronary balloon approved for use in the U.S. and currently indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
According to Company, the patent has profound business implications for Inspira and for its ability to dominate a market with a potential size of $20 billion.
It looks at the rise of fraudulent research and scientists in the life sciences industry, the reasons for the rise, and suggests some measures that companies can take to counter this growing threat to the reputation of the industry and to the safety and security of healthcare delivery.
89% of KLAS-surveyed customers use Xsolis’ AI technology to minimize preventable denials.